PRogram to Improve Stress-levels and Enhance Memory — PRISEM  

Mild Cognitive Impairment Clinical Trial

Official title: PRogram to Improve Stress-levels and Enhance Memory

Status Recruiting

Clinical Trial Summary

This is a 2-arm intervention pilot study with the objective to examine if an in-person and a remote multi-component intervention program can improve chronic stress, vascular measures, and executive function among African American and White patients with Mild Cognitive Impairment. Researchers plan to enroll 60 participants with over-recruitment of African American patients. 30 participants will be recruited from the Cognitive Empowerment Program to participate in PRogram to Improve Stress-levels and Enhance Memory (PRISEM) Cognitive Empowerment Program (CEP) (i.e., in-person lifestyle intervention program) and 30 participants will be recruited from Emory primary care clinics to participate in PRISEM Remote (i.e., remote lifestyle intervention program). The participants in both intervention arms will be asked to participate in group-based and/or individual activities that focus on improving health education, nutrition, physical activity, cognitive health, stress levels, and overall well-being. The duration of the study for all participants will be 9 months with 3 study visits. At each study visit, the following measures will be assessed: psychosocial, behavioral, vascular/physical, and executive function.

Clinical Trial Description

More than half the patients with Mild Cognitive Impairment (MCI), a transitional state between normal aging and dementia, will develop dementia within five years. Despite the clinical and public health significance of MCI, there are no known pharmacological treatment strategies preventing the progression to Alzheimer's Disease (AD). Disappointing results from clinical trials of AD-modifying interventions have increased efforts to focus on prevention strategies that delay the onset of the disease. Since AD-related pathology begins more than a decade before patients develop symptoms, prevention efforts are likely to be more effective when targeted earlier in life. Data is even more limited on higher risk groups such as African Americans who have double the incidence compared with Whites.

This study plans to enroll a diverse population with an over-enrollment of African Americans because African Americans have a higher risk of developing mild cognitive impairment (MCI) and double the incidence of Alzheimer's Disease (AD) compared with Whites. Unfortunately, prevention and management of MCI have been understudied among African Americans. Chronic stress (such as perceived discrimination, and daily environmental stress) in African Americans can affect cognition and plays a role in the worsening of unhealthy behaviors such as smoking, improper diet, and physical inactivity.

Recent studies have predicted that a 10-25% reduction in seven key modifiable risk factors, including behavioral and lifestyle choices, could prevent 1.3 million AD cases globally. Healthy lifestyle approaches can reduce oxidative stress, produce structural and functional changes in the brain, and also influence the rate of neurogenesis in adult and senescent animal models. However, interventions that improve these have been often disappointing, in part because the impact of each lifestyle behavior on AD risk is relatively small.

The aim of this pilot study is to evaluate how an in-person and remote multicomponent lifestyle intervention program improves mood symptoms (chronic stress), and positively impacts biomarkers of vascular health and autonomic nervous system among forty African American and White patients with MCI. ;

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

• NCT number: NCT05845918
• Study type: Interventional
• Source: Emory University
• Contact: Ambar Kulshreshtha, MD, PhD
• Phone: 404-778-6910
• Email: mindandheart@emory.edu
• Status: Recruiting
• Phase: N/A
• Start date: February 21, 2023
• Completion date: March 31, 2025